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CompletedNCT04861935Updated Feb 24, 2023

Ultrasound Guided Investigation Of The Anatomical Features For Caudal Block In Children With Sacral Dimple

An interventional study of ultrasound evaluation in Sacrococcygeal Disorder, sponsored by Istanbul University. Completed at 1 site in Turkey. Open to participants aged 1 Month to 72 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-24.

Sponsored by Istanbul University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
1 Month to 72 Months
Sex
All
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Study summary

When dimples are detected in the sacral region, most practitioners consider it to be a sign of spinal anomaly and avoid caudal block. Ultrasound guided investigation of the anatomical features for caudal block in normal children and in children with sacral dimple will be informative for practitioners.

Read the detailed description

A dimple over the sacrum may be an isolated finding or a sign of underlying spinal abnormality. Therefore, most practitioners are confused to perform a caudal block. Ultrasonography is a safe and cost effective screening tool in pediatric patients. Ultrasound guided investigation of the anatomical features of sacral region may play a key role to eliminate suspicions. It is possible to detect spinal abnormalities and also measuring dural sac level, distance between dural sac and estimated needle insertion site or needle entry angle. In this study, we will examine whether there is a difference between normal children and children with dimple in the sacral region.

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Conditions studied

  • Sacrococcygeal Disorder

Keywords

  • pediatric, sacral dimple, ultrasound
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In context

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 72 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

-Children aged 1-72 months who are taken to the operating room for any reason

Exclusion Criteria: Patients with

  • spinal anomalies,
  • history of prematurity,
  • neurological disorder
  • syndromic illness.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Placebo comparator
    ultrasound evaluation of sacral region in normal pediatric patients

    Ultrasound evaluation of sacral region will be performed to detect spinal abnormality. Dural sac level and its distance to estmated injection site, optimal entry angle for caudal block will be measured.

    Device: ultrasound evaluation

  • Active comparator
    ultrasound evaluation of sacral region in patients with sacral dimple

    Ultrasound evaluation of sacral region will be performed to detect spinal abnormality. Dural sac level and its distance to estmated injection site, optimal entry angle for caudal block will be measured.

    Device: ultrasound evaluation

Interventions

  • Deviceultrasound evaluation

    ultrasound evaluation of normal patients and patients who have a sacral dimple

06

What researchers measure

Primary outcomes

  1. ultrasound measurement-1

    Dural sac level (mm)

    Time frame: 1 min

  2. ultrasound measurement-2

    distance between injection site and dural sac(mm)

    Time frame: 1 min

  3. ultrasound measurement-3

    optimal entry angle (0-angle degree) for caudal block

    Time frame: 1 min

Secondary outcomes

  1. ultrasound evaluation of sacral region

    searching for spinal abnormalites in patients with sacral dimple

    Time frame: 10 minutes

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Study locations

1 site
  • Istanbul University Cerrahpasa
    Istanbul, 34000, Turkey
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References and documents

Publications

  • Schwartz D, Al-Najjar H, Connelly NR. Caudal block in a child with a sacral dimple utilizing ultrasonography. Paediatr Anaesth. 2011 Oct;21(10):1073-4. doi: 10.1111/j.1460-9592.2011.03621.x. No abstract available. PubMed 21981093 ↗
  • Choi JH, Lee T, Kwon HH, You SK, Kang JW. Outcome of ultrasonographic imaging in infants with sacral dimple. Korean J Pediatr. 2018 Jun;61(6):194-199. doi: 10.3345/kjp.2018.61.6.194. Epub 2018 Jun 25. PubMed 29963103 ↗

Individual participant data

Plan to share: No — There is not a plan to make IPD available.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04861935
Lead sponsor
Istanbul University
Responsible party
Celal Kaya (Principal Investigator, MD, Istanbul University) — Principal investigator
First posted
Apr 27, 2021
Start date
Nov 11, 2022
Primary completion
Feb 11, 2023
Completion
Feb 11, 2023
Last update
Feb 24, 2023

Study contacts

Guner Kaya, Prof.
study director · Istanbul University - Cerrahpasa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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